HIV drug lawsuits filed against Gilead Science, Inc. in the state of California will undergo coordinated discovery in San Francisco Superior Court.
In recent months, hundreds of plaintiffs have filed more than two dozen personal injury claims throughout California that seek compensation for bone and kidney injuries allegedly caused by tenofovir disoproxil fumarate (TDF). TDF is the active ingredient in Gilead’s Viread, Truvada, Atripla, Complera, and Stribild, all of which are indicated to treat, and in some cases prevent, HIV-1.
Arguing that the growing docket would benefit from coordinated discovery and other pretrial proceedings, plaintiffs recently filed a petition with the Judicial Counsel for the State of California requesting all Gilead HIV drug lawsuits be centralized in a single Superior Court.
Judge Kenneth R. Freeman granted their petition last week and ordered the cases transferred to San Francisco. The new proceeding is entitled: Gilead Tenofovir Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 5043.
Gilead received U.S. Food and Drug Administration approval for Viread, the first TDF-based HIV medication, in October 2001. Eventually, the agency would go on to approve the company’s Truvada, Atripla, Complera, and Stribild. The first of Gilead’s TDF patents are set to expire 2021, at which point the highly-profitable franchise will begin to face lower-cost generic competition in the United States.
Gilead also developed tenofovir alafenamide fumarate (TAF) in 2000, which it knew to be less toxic to the kidneys and bones compared to TDF. In 2004, however, the company decided to shelve its TAF project, claiming the drug was too similar to TDF to justify its continued development.
But TAF would eventually come to market in 2015, when Gilead launched Genvoya. The company has since introduced two TAF-based HIV drugs Odefsey and Descovy. Patents for Gilead’s TAF franchise will not begin expiring until 2032.
Plaintiffs pursuing HIV lawsuits in California claim that the TAF delay was actually intended to protect profits derived from Gilead’s valuable TDF patents. By waiting to launch Genvoya in 2015, the company gave itself years to hype TAF’s superior safety profile and convince doctors and patients to adopt the new drug long before its first TDF patents expire in 2021.
The purported strategy allowed Gilead to “reap outsized profits” from the high costs of its TDF medication franchise, while restricting “patient access either through exorbitant out-of-pocket costs or co-pays, limitations in existing insurance, and rationing of these high-priced pills.”